Solitary Pulmonary Nodules
Conditions
Keywords
pulmonary nodule
Brief summary
The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.
Detailed description
The acquisition system will consist of using site equipment including the CARESTREAM DRX-Evolution x-ray system, and the predicate CARESTREAM DRX Plus detector and the investigational DE-DT application. DE Study Design Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue). DT Study Design Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images. 11 phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Interventions
RADIATIONRadiation
Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. Phantoms were imaged using linear tomography and digital tomography.
Sponsors
Carestream Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age 18 years and older. Subject has provided informed consent. Study participant is scheduled to have a chest CT exam. Study participant is able to stand and be still during the exams.
Exclusion criteria
Human subject specific: Not able or willing to provide Informed Consent, or consent is withdrawn. Study participant is a female of child bearing age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume | 3 month | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
| Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images | 3 months | 1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Predicate & Invest. DE - Human Subjects Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. | 37 |
| Predicate & Invest. DT - Human Subjects Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. | 18 |
| Predicate & Invest. DT - Phantom Images Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.
Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. | 11 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | equip. image processing issue | 5 | 1 | 0 |
Baseline characteristics
| Characteristic | Predicate & Invest. DE - Human Subjects | Predicate & Invest. DT - Human Subjects | Predicate & Invest. DT - Phantom Images | Total |
|---|---|---|---|---|
| Age, Customized > 18 years | 37 years | 18 years | 11 years | 66 years |
| Sex/Gender, Customized unknown | 37 participants | 18 participants | 11 participants | 66 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 17 | 0 / 11 |
| serious Total, serious adverse events | 0 / 32 | 0 / 17 | 0 / 11 |
Outcome results
Primary
Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite | 3.3214 units on a scale | Standard Error 0.0242 |
p-value: 0Equivalence test
Primary
Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy | 3.2911 units on a scale | Standard Error 0.0178 |
p-value: 0Equivalence test
Primary
Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy | 3.5504 units on a scale | Standard Error 0.0163 |
p-value: 0t-test, 1 sided
Primary
Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
Population: 224 image ratings from 7 radiologist readers (32 images rated x 7 readers) for Predicate \& Invest. DE - Human Subjects arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest | 3.4540 units on a scale | Standard Error 0.0183 |
Primary
Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
Population: 77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate \& Invest. DT - Phantom Images arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images | 3.7156 units on a scale | Standard Error 0.0268 |
Primary
Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 month
Population: 119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for DT Investigational - Scout \& DT Volume.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume | 3.6277 units on a scale | Standard Error 0.023 |
Primary
Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
Population: 119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate \& Invest. DT Reference 1 - PA Chest arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest | 3.4832 units on a scale | Standard Error 0.0228 |
p-value: 0t-test, 1 sided
Primary
Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
Population: 119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate \& Invest. DT Reference 2 - PA and LAT Chest arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest | 3.5546 units on a scale | Standard Error 0.019 |
p-value: 0.007t-test, 1 sided
Primary
Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images
1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.
Time frame: 3 months
Population: 77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate \& Invest. DT - Phantom Images arm above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Predicate & Invest. DE - Human Subjects | Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images | 3.3494 units on a scale | Standard Error 0.0433 |
p-value: 0t-test, 1 sided